Designing a Clinical Protocol for Vaccine Clinical Trial April 3, 2013

This training on vaccine clinical trials compliance will discuss the crucial points that need to be addressed when designing a clinical protocol for testing candidate vaccines. It will address the most common mistakes and issues and how they can adversely affect the vaccine candidate approval.

Why Should You Attend:

If your vaccine candidate is in pre-clinical stage but you are planning to start testing it in humans soon, this webinar is for you and your staff. If you have clinical trials that are on hold, are dragging on and you are experiencing frequent delays caused by FDA hold, this webinar is for you.

This course will provide guidance in designing and writing clinical protocols for testing vaccine candidates. We will talk about the special considerations that one needs to have in mind when designing vaccine trials. The presenter will address the most common mistakes that are made and how these mistakes affect the start and conduct of the trial and can considerably extend the timeline for the vaccine candidate approval and drain the assigned budget. Specific issues, pertinent to vaccine clinical trials will be discussed for each of the phases of clinical trials.

The webinar will include strategies to avoid delays caused by FDA holds as well as strategies on how to address FDA concerns.

Areas Covered in the Webinar:

- Vaccine candidate testing on healthy individuals.
- Vaccine candidates testing in children.
- How to set up the safety oversight section.
- First in man studies.
- Special considerations for successful Phase 1
- Special considerations for successful Phase 2
- Special considerations for successful Phase 3
- Testing vaccines in the developing world.